Pharma Patent Law & Recent Trends - India

Dr. Kalyan C. Kankanala Vikram Pratap Singh Thakur

© 2011 BananaIP

Patent Law EvolutionPatent Act

First Patent legislation - Act VI of 1856 Patent Act, 1970 (brought into force w.e.f. 20th April, 1972)

Patents (Amendment) Act, 1999 Patents (Amendment) Act, 2002 Patents (Amendment) Act, 2005

Patent Rules Patents Rules, 1972 (brought into force w.e.f. 20th April, 1972)

Patents (Amendment) Rules, 2005 Patents (Amendment) Rules, 2006

Patent Manual Draft Patent Manual 2010

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A few important changes

From 1.1.1995 Mail-Box for pharmaceutical and agrochemicals

products Exclusive Marketing Rights

From 1.1.2000 Patent term increased to 20 years Definition of invention – inclusion of inventive

step Right of patentee (importation also included)

From 1.1.2005 Product patents for food, chemical and

pharmaceutical

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Patentability Requirements

Subject matter

Industrial applicability

Novelty

Inventive step

Specification

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Subject MatterPatentable Subject Matter

Product or process

Non Patentable subject matter 3 (d)

New form Efficacy

New property or new use Mere use of a known process

New product New reactant

Explanation- salts, esters, ethers, polymorphs, metabolites, pure form, particle size, isomers, mixtures of isomers, complexes, combinations and other derivatives of known substance shall be considered to be the same substance. efficacy

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Novartis case 3(d)Imatinib Masylatebeta crystal form of Imatinib Masylate, which is non-needle shaped, having better flow properties, thus better processible, less hygroscopic and more thermodynamically stable, thus better storable than its needle shaped, alpha crystal form,

Pre grant opposition

Increased efficacy (therapeutic effect in healing a disease)

Challenged constitutional validity of sec. 3(d) Not vague, ambiguous and arbitrary Section along with explanation – clear and has inbuilt measures to

guide controller

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Non Patentable subject matter 3 (e) Mere admixture

Aggregation of properties Synergistic effect

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Industrial Applicabilitycapable of industrial application

Test Make Repeat Use

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NoveltyAnticipation:Public knowledge or public use

Exemption - Secret usePrior publication

Wrongful obtainment Govt. Learned society

Grace periodOn sale

Reasonable trialPublic display

Central govt. notified exhibition Grace period

Public working Reasonable trial

Grace period

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Inventive StepTechnical advance as compared to the existing knowledge ; or having economic significance; or both

not obvious to a person skilled in the art

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Hoffmann-La Roche v. Cipla

Human epidermal growth factor type 1 / epidermal growth factor receptor (Her/Egfr) inhibitor popularly known as Erlotinib

Clarified the concept of inventive step

Test of obviousness– whether in light of prior art, it was possible for a normal but unimaginative person skilled in the art to discern the inventive step of the invention on the basis of general common knowledge of the art at the priority date.Whether the differences between the prior art would, without knowledge of the alleged invention, constitute steps which could have been obvious to the skilled man or whether they required any degree of invention

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SpecificationWritten DescriptionEnablementBest modeClaims

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Controller DecisionNovartis patent IN212199 claiming single-pill combination of aliskiren and valsartan marketed as Valturna rejected

Post grant opposition by Sun pharma lack of inventive step, insufficient disclosure, not an

invention and non-patentable under the Act

Claims amendedNone of examples exemplified the compositions of amended claims.

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Filing

Publication

18 months

FER

Putting app in order for grant

6 months

12 months

Request for Examination

48 months

6 months

Patent Process

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OppositionPre grant

Post grant

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CaseBayer’s IN/PCT/2002/410/CHE claiming contraceptive formulation of drospirenone and ethinylestradiol (EE) marketed as Yasmin and Yaz/Yasminelle in Europe and the US refusedOpposed by cipla and natcoThe decision was more or less influenced by the District Court and the CAFC decisions in Bayer Schering Pharma AG v. Barr Laboratories, Inc. which held US6787531 obvious and invalid.Equivalent of ‘531 patent“obvious-to-try” test

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InfringementLiteral infringement

Infringement by equivalence Substantial equivalence test

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Infringement examplesLallubhai Cakubhai Jariwala v. Chimanlal Chunilal Process of treating dry fruits

Sulphuric acid – washing soda 3% bleaching solution – 4 and 2 % bleaching solution Acetic acid – Muriatic acid Sulphur dioxide fumes under presssure – sulphur

dioxide fumes without pressure

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DefensesPatent invalidGovt. useResearch exemptionParallel imports

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Compulsory LicensingSection 84Application for compulsory license

(a) that the reasonable requirements of the public not been satisfied, or

(b) that the patented invention is not available to the public at a

reasonably affordable price, or (c) that the patented invention is not worked in the

territory of India.

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Compulsory license for export Country having Insufficient or no manufacturing

capacity in pharma sector to address public health problem

Such Country Granted compulsory Allowed importation

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Recent Trends

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Prosecution HistoryTraditionally this communication was treated by the patent office as confidential

Complete Specifications of only granted patents were available

As per notification of April 15, 2010; patent office to supply upon request all correspondence between the applicant and patent office

Helpful for pre grant opposition

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Prosecution History Estoppel (PHE)Well accepted principle internationally

No case supporting the principle in India

Making available the entire prosecution history on request may lead towards PHE

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Speaking OrderPatent application for a molecule used in the treatment of diabetes

First Examination Report “…The molecule lacks novelty and inventive step

because it forms part of a publication in a text that discloses a herbal extract for diabetes treatment.”

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Applicant responds by giving a detailed explanation of differences between the extract disclosed in the text and the molecule. Applicant further states that a hearing must be given before making an adverse decision.Second Examination Report-

“…The molecule lacks novelty and inventive step because it forms part of a publication in a text that discloses a herbal extract for diabetes treatment.”

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First Examination Report “…The molecule lacks novelty and inventive step

because it forms part of a publication in a text that discloses a herbal extract for diabetes treatment.”

Second Examination Report- “…The molecule lacks novelty and inventive step

because it forms part of a publication in a text that discloses a herbal extract for diabetes treatment.”

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Not a speaking Order

Hearing must be given- adherence to principles of natural justiceMagical Sentence- “Kindly provide hearing in case of adverse decision on the application.”Valencia CTT v. Union of India (decided on 26th Feb 2010)

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Abandonment v. RefusalAbandonment

Application considered abandoned if all requirements not complied with

Cannot be appealedRefusal

General power of the Controller to Refuse Can be appealed

Patent Office Practice- Application abandoned whether reply to examination

report filed or not.

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Ericsson v. UOI (Decided on March 11, 2010)29th July 2005- Ericsson filed national phase patent application8th October 2007- First Examination report issued and defects pointed out which was replied on 10th Dec. 200725th July 2008- Another examination report sent by controller restating points already mentioned in first information report. Replied on 22nd Sept 200810th October 2008- Patent office wrote a letter to the petitioner stating that despite response of the petitioner on 22nd September 2008, the specification of the petitioner was still defective on various grounds and the application was deemed to be abandoned under section 21(1).

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Delhi High Court Held:Abandonment-

When reply to examination report is not filed at all.

Refusal-If reply is filed then the application cannot be

abandoned and has to be refused.

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Patent Law and LinkageBayer Corporation v. Union of India

Decided on 9th Feb 2010

CIPLA filed for a drug license for the generic drug ‘Soranib’.Bayer corporation sent a letter to the drug controller requesting him not to grant approval as Bayer holds a patent on ‘Sorafenib Tosylate’ and Soranib is a substitute of their patented drug.Drug Controller granted the drug license.

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Bayer filed a petition in the Delhi High Court against the approval granted by the Drug Controller.Bayer’s contention- If drug controller had previous knowledge of potential patent violation he should not grant approval.Decision- Drug Controller doesn’t have to travel beyond the scope of Drugs & Cosmetics Act and rules. Shouldn’t refuse license on the pretext of possible violation of a patent.

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2010 Patent draft manual released

Scientific advisors

Application status search available

TKDL involved in rejection and withdrawal of patent application

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